Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Encinitas, California and other locations
Dates
study started
estimated completion

Description

Summary

To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Official Title

MAGNETISMM-1 A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) - CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT AND IN COMBINATION WITH IMMUNOMODULATORY AGENTS IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)

Details

Study C1071001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic study of PF-06863135 in adult patients with advanced multiple myeloma who have relapsed from or are refractory to standard therapy. This is a two part study; Part 1 will assess the safety and tolerability of increasing dose levels of PF-06863135 and Part 2 will evaluate safety and anti-myeloma activity of PF-06863135 at the RP2Ds determined in Part 1.

Keywords

Multiple Myeloma, relapse/ refractory multiple myeloma, bispecific antibody, bispecific, BCMA, BCMA- CD3 bispecific, Phase 1, PF-06863135, dexamethasone, lenalidomide, pomalidomide, Plasma Cell Neoplasms, Thalidomide, Dexamethasone acetate, Antibodies, Immunoglobulins, Bispecific Antibodies, BB 1101, PF-06863135 monotherapy IV or SC, PF-06863135 + dexamethasone, PF-06863135 + lenalidomide, PF-06863135 + pomalidomide

Eligibility

You can join if…

Open to people ages 18 years and up

  • Relapsed/refractory multiple myeloma
  • Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
  • Performance Status of 0- 1 ( Performance Score 2 is permitted only if due to underlying myeloma)
  • Adequate bone marrow, hematological, kidney and liver function
  • Resolved acute effects of any prior therapy to baseline severity
  • Not pregnant

You CAN'T join if...

  • Recent history of other malignancies
  • History of active autoimmune disorders
  • Any form of primary immunodeficiency
  • Active and clinically significant bacterial, fungal, or viral infection
  • Evidence of active mucosal or internal bleeding
  • History of severe immune-mediated adverse event with prior immunomodulatory treatment
  • Major surgery within 4 weeks of study treatment start
  • Radiation therapy within 2 weeks of study treatment start
  • History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment
  • Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry
  • Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy
  • Requirement for systemic immune suppressive medication except as permitted in the protocol
  • Current requirement for chronic blood product support

Locations

  • UCSD Medical Center - Encinitas
    Encinitas California 92024 United States
  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital)
    La Jolla California 92037 United States
  • UC San Diego Moores Cancer Center
    La Jolla California 92037 United States
  • UC San Diego Medical Center - Hillcrest
    San Diego California 92103 United States
  • UCSD Medical Center - Vista
    Vista California 92081 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT03269136
Phase
Phase 1 Multiple Myeloma Research Study
Study Type
Interventional
Participants
About 101 people participating
Last Updated